Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

First patients recruited into Ondine’s Steriwave ICU pilot study

Ondine Biomedical (LON:OBI) announced the initiation of patient recruitment for an intensive care unit (ICU) pilot study at Royal Columbian Hospital (RCH) in New Westminster, British Columbia. The company states that...

March 20, 2025

Developments

USPO issues NOA to Sonnet for second IL-18 protein patent

Sonnet BioTherapeutics (NASDAQ:SONN) announced that the United States Patent and Trademark Office (USPTO) has granted a notice of allowance (NOA) for a second patent in the IL-18 variant protein field. According to...

March 19, 2025

Developments

Bioxytran signs NDA with UGA to evaluate galectin antagonist for bird flu

Bioxytran (QTCQB:BIXT) announced that it has signed a non-disclosure agreement (NDA) with the board of regents of the University System of Georgia, University of Georgia (UGA), to collaborate on evaluating its galectin...

March 19, 2025

Developments

Final patient enrolled in Biofrontera’s Phase 3 trial of Ameluz in AKs

Biofrontera (NASDAQ:BFRI) announced completion of patient enrollment in the Phase 3 study of Ameluz topical gel for the treatment of Actinic Keratoses (AKs) on the extremities, neck, and trunk with photodynamic therapy...

March 18, 2025

Developments

Capricor reveals positive data from HOPE-2 trial of deramiocel in DMD

Capricor Therapeutics (NASDAQ:CAPR) announced positive long-term data from its on-going HOPE-2 trial demonstrating the potential of its lead candidate, deramiocel, to slow disease progression and preserve upper limb...

March 17, 2025

Developments

Perimeter reaches regulatory milestone with FDA PMA submission for next-gen B-Series OCT with ImgAssist AI 2.0

Perimeter Medical Imaging AI (TSXV:PINK; OTCQX:PYNKF) announced that it has filed a premarket approval (PMA) application for its next-generation B-Series OCT system, which combines proprietary AI technology with optical...

March 17, 2025

Developments

Biovica partners with Outcomes4Me to support HR-positive mBC patients

Biovica International (STO:BIOVIC-B; FRA:911) announced that it has partnered with Outcomes4Me to support post-menopausal patients with hormone (HR)-positive metastatic breast cancer (mBC) in understanding treatment...

March 12, 2025

Developments

Atossa announces plan to pursue MBC indication for (Z)-endoxifen

Atossa Therapeutics (NASDAQ:ATOS) announced its decision to pursue a metastatic breast cancer (MBC) indication for (Z)-endoxifen. According to Attosa, it also plans to work with the FDA to advance additional...

March 11, 2025

Developments

Trevi reports positive Phase 2a trial data of Haduvio for RCC

Trevi Therapeutics (NASDAQ:TRVI) announced positive topline results from its Phase 2a RIVER study of oral nalbuphine ER (Haduvio) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF)...

March 10, 2025

Developments

PDS launches Phase 3 trial for HNSCC

PDS Biotechnology (NASDAQ:PDSB) announced that it has commenced its Phase 3 trial, VERSATILE-003, to evaluate the efficacy and safety of Versamune HPV plus pembrolizumab for head and neck squamous cell carcinoma (HNSCC)...

March 10, 2025

Developments

Covenant Health Fort Sanders first in Tennessee to use Perimeter’s pioneering AI-driven OCT cancer margin visualization technology

Perimeter Medical Imaging AI (TSX-V:PINK; OTCQX:PYNKF) announced that Covenant Health Fort Sanders Regional is the first hospital in Tennessee to implement its optical coherence technology (OCT) technology, S-Series...

March 6, 2025

Developments

Oragenics submits IB for Phase 2 trial of ONP-002 in mTBI

Oragenics (NYSE American:OGEN) announced the submission of an Investigator Brochure (IB) in preparation for its Phase 2 trial evaluating ONP-002 for mild traumatic brain injury (mTBI), commonly known as concussion...

March 6, 2025

Developments

SIR accepts Autonomix abstract showcasing study results

Autonomix Medical (NASDAQ:AMIX) announced that the Society of Interventional Radiology (SIR) has accepted its abstract highlighting its technology and early proof-of-concept study results for a poster presentation at...

March 6, 2025

Developments

EPO to grant Moleculin’s Annamycin new patent allowances strengthening global exclusivity

Moleculin Biotech (NASDAQ:MBRX) announced that it received a Notice of Intent to Grant from the European Patent Office (EPO) for its patent application covering Annamycin, a potential next-generation, non-cardiotoxic...

March 6, 2025

Developments

Arch announces non-brokered private placement

Arch BioPartners (TXSV:ARCH; QTCQB:ACHFF) has arranged a non-brokered private placement of 225,806 common shares at $1.55 per share, generating proceeds of CAD $350,000. According to Arch, the offering, set to close...

March 5, 2025

Developments

ASBrS selects Perimeter’s B-Series OCT with ImgAssist AI 2.0 pivotal trial results for presentation at 2025 annual meeting

Perimeter Medical Imaging AI (TSXV:PINK; OTCQX:PYNKF) announced that detailed results from its pivotal trial evaluating the next-generation B-Series OCT with ImgAssist AI 2.0 for breast-conserving surgery (BCS) will be...

March 5, 2025

Developments

Stereotaxis submits EMAGIN robotic catheter for FDA clearance

Stereotaxis (NYSE:STXS) has announced that it has submitted its robotically navigated catheter, EMAGIN 5F, for FDA regulatory clearance. According to Sterotaxis, EMAGIN 5F, short for endovascular magnetic intervention...

March 3, 2025

Developments

Personalis spotlights new publication from ICR and Royal Marsden on ctDNA testing in MRD

Personalis (NASDAQ:PSNL) in collaboration with the Institute of Cancer Research (ICR), London, and the Royal Marsden NHS Foundation Trust, UK, has announced published results from its early-stage breast cancer study in...

March 3, 2025

Developments

Kairos presents positive preclinical outcomes of anti-tumor therapies at AACR IO

Kairos Pharma (NYSE:KAPA) announced the presentation of positive preclinical data on its investigational compounds KROS 101 and KROS 401 during the American Association for Cancer Research and Immuno-Oncology (ACCR IO)...

February 26, 2025

Developments

Alligator reports encouraging OS for mitazalimab in metastatic pancreatic cancer

Alligator Bioscience (STO:ATORX) has announced updated results from its Phase 2 OPTIMIZE-1 study evaluating mitazalimab in combination with chemotherapy as a first-line treatment for metastatic pancreatic cancer...

February 26, 2025

Developments

IP highlights Istesso’s Phase 2b study findings of leramistat in RA

IP Group (LSE:IPO) has reported that Instesso has provided its shareholders with the results of its 12-week randomized, double-blind, placebo controlled Phase 2b study of leramistat in patients with moderate-to-severe...

February 25, 2025

Developments

First patient dosed in Aim’s Phase 2 study of Ampligen and Imfinzi in pancreatic cancer

AIM ImmunoTech (NYSE American:AIM) announced that the first new patient has been dosed in the Phase 2 study of its Ampligen and Astra Zeneca’s anti-PD-L1 immune checkpoint inhibitor, Imfinzi, as a potential combination...

February 25, 2025

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